The Effect of Ideal Birth Environment on Birth Pain, Fear of Childbirth, Mode of Delivery and Duration of Delivery

December 20, 2024 updated by: Sema Göçmez, Mehmet Akif Ersoy University

The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery.

on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

Detailed Description

The birth environment filled with medical instruments increases the level of anxiety and fear in the mother.

increase, disrupting the neurohormonal relationship that ensures the normal functioning of labor and an increase in the rate of cesarean section deliveries. Also women when she does not feel safe in her environment and her baby does not feel safe, the birth process is temporary. may slow down as a result release of adrenaline (epinephrine) and noradrenaline (norepinephrine) as a result of stress and anxiety increases, creating a "fight or flight" situation in the woman. Adrenaline and noradrenaline are the main

towards the end of labor to help the fetus to expel, while towards the end of labor should be at a low level at the beginning. The woman cannot fight stress in these cases, adrenaline and noradrenaline levels increase, while oxytocin levels decrease. This one from a physiological point of view, it can cause the progression of labor to stop, the duration prolonged labor and increased cesarean section rates. In a study conducted with pregnant rats, noise and movement in the birth environment restriction has been found to negatively affect hormones involved in labor

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bucak
      • Burdur, Bucak, Turkey, 15300
        • Mehmet Akif Ersoy Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

18-35 years old pregnant primiparous literate

Exclusion Criteria:

Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)

  • Psychiatric illness such as anxiety and depression
  • Communication barrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
will receive standard care, no intervention will be performed
Active Comparator: ideal birth environment

ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice.

There will be a companion, a birthing ball and chair, and the room will allow freedom of movement.

It will be designed to allow

ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice.

There will be a companion, a birthing ball and chair, and the room will allow freedom of movement.

It will be designed to allow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version
Time Frame: 28-36 weeks of gestation

Wijma Birth Expectancy/Expectation Scale A Version (W-DEQ A), W-DEQ consists of 33 items and is a six-point Likert-type scale.

Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all".

is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear.

is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced.

is high.

  • W-DEQ score? 37 mild,
  • W-DEQ score = 38-65 moderate,
  • W-DEQ score = 66-84 in severe degree,
  • A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement.

The alpha value of the scale is calculated by inverting the scale in the opposite direction. Cronbach's alpha value of the scale 0.89 (Korukcu et al., 2012) Wijma Birth Anticipation/Experience Sc

28-36 weeks of gestation
VASA Pain Assessment Scale
Time Frame: during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
Quantitative pain rating scale (QPRS) is used to assess the severity of pain. is used. On a numerical rating scale, pain ranges from 0 (no pain) to 10 (unbearable pain) score (Price et al., 1983).
during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
WIJMA BIRTH EXPECTANCY/EXPERIENCE SCALE B VERSION
Time Frame: up to the first 12 hours after birth

he W-DEQ consists of 33 items and is a six-point Likert-type questionnaire. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all".

is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear.

is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced.

is high.

  • W-DEQ score? 37 mild,
  • W-DEQ score = 38-65 moderate,
  • W-DEQ score = 66-84 in severe degree,
  • A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement.

is calculated by inverting it in the opposite direction in order to provide

Translated with www.DeepL.com/Translator (free version)

up to the first 12 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • GO 2024/510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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